Dear Colleagues --
In view of the dynamic developments in the hemp oil/CBD category, we have approached the Executive Advisory Committee and received support to form a new Hemp Oil/CBD committee within UNPA. The initial objectives and parameters of the committee are found in the attached memo to the EAC below.
We strongly sense the need to discuss and develop policy and guidelines for our membership. Some of our members have jumped into the category. Others are considering, and some are really unsure what to do. This we fully understand.
Please e-mail Heidi Calder (firstname.lastname@example.org) if you wish to join the committee. I ask that you contact her at your earliest convenience, as the first committee meeting (likely a conference call) will be organized very soon, in the view of fast-moving events. From this point Frank Lampe will be the liaison for UNPA. The work of this committee will be fast moving, interesting, and hopefully very helpful to provide guidance to our members and colleagues in the industry.
---------- Forwarded message ----------
From: Loren Israelsen <email@example.com>
Date: Thu, May 24, 2018 at 5:53 PM
Subject: Hemp oil / CBD -- proposal to form committee
To: Frank Lampe <firstname.lastname@example.org>, Greg Ris <email@example.com>, Jim Emme <firstname.lastname@example.org>, Jonathan Pinkus <email@example.com>, Ken Myers <firstname.lastname@example.org>, Kevin McMurray <email@example.com>, Kim Pearson <KPearson@thorne.com>, Kira Olsen <firstname.lastname@example.org>, Kirk Jowers <email@example.com>, Larisa Pavlick <firstname.lastname@example.org>, Larry Kolb <email@example.com>, Paul Konney <PaulKonney@metagenics.com>
Dear Executive Advisory Committee Members --
The topics of hemp oil/CBD (hereafter "HO/CBD") were discussed as part of our retreat agenda. Roy Bingham of BDS Analytics gave a useful market overview presentation, which we will soon make available to the general membership, and Marielle Weintraub (Covance) presented on testing and technical issues around HO/CBD.
There were may questions from attendees, with many more issues we were unable to cover, given time and the scope of expertise.
We are also fielding frequent member calls asking for advice about entering the HO/CBD market. We have, to this point, maintained an issue-neutrality status, and our advice to members reflects this. In separate discussions with Ikhlas Khan at NCNPR, various hemp industry lawyers, FDA staff, and others, we are now of the view that HO/CBD is a significant, highly complex, and now DSHEA industry-related subject. Many hemp oil and CBD oil products are labeled and sold as dietary ingredients/supplements. There is clear disagreement over the regulatory status of these products, which has created significant DSHEA-related issues.
In addition, I am in communication with GW Pharmaceutical. (Their U.S. entity is named Greenwich Biosciences because of a trademark problem with GW). I am informed that GW's cannabidiol drug application will be approved June 27, 2018. What happens thereafter remains to be seen. I have built up a very strong and trusted relationship with senior management at GW, and they express an interest in an open dialogue with key members of our industry to discuss how their approved drug and general sale hemp oil/CBD products might remain on the market. A key discussion, indeed.
For these reasons, we propose to form a UNPA HO/CBD committee.
Please note we do not propose to include psychoactive cannabis or its synonyms in the name or scope of work for this committee. We believe the medical and recreational uses of cannabis are beyond the scope of UNPA's mandate and currently outside DSHEA-related policy or regulatory issues.
The proposed scope of the committee would include:
1. Establishing liaison with other respected organizations involved in the HO/CBD sector, such as AHPA, the Industrial Hemp Association, NCNPR's cannabis research program, NIH, DEA, FDA, and other similar parties.
2. Monitoring legislation, regulation, and policy changes at state and federal levels that affect the status of HO/CBD products.
3. Gaining expertise on market trends.
4. Developing, as appropriate, internal policy positions regarding HO/CBD -- particularly involving DSHEA, definitions, NDI/ODI policy, and the race-to-market provision that will soon be triggered by GW Pharma's entry with a new, approved drug based on CBD.
5. Providing member news, learning opportunities, and discussion forums within UNPA and at industry events.
6. Specific legal guidance on the uneven and confusing federal regulatory morass to help members decide about going into this business. Risks v. rewards? State-by-state analysis? Cross-state distribution and testing issues?
7. Technical information about testing and analysis.
UNPA staff liaison -- Frank Lampe
Committee Chair -- TBD
The committee would be open to all UNPA members with an interest in this topic and invited external experts and advisors to participate as non-voting members.